HIV Clinical Trials Top Leaders and Corporate Growth

Which are the Top Companies in the HIV Clinical Trials Market?

• Gilead Sciences
• ViiV Healthcare
• GlaxoSmithKline (GSK)
• Janssen Pharmaceuticals (Johnson & Johnson)
• Merck & Co. (MSD)
• Pfizer
• Bristol-Myers Squibb
• AbbVie
• Sanofi
• Moderna
• BioNTech
• Novavax
• Sangamo Therapeutics
• IQVIA
• ICON plc

Market Growth

The global HIV clinical trials market size is calculated at US$ 1.27 billion in 2024, grew to US$ 1.36 billion in 2025, and is projected to reach around US$ 2.54 billion by 2034. The market is expanding at a CAGR of 7.17% between 2025 and 2034.

HIV Clinical Trials Market Trends

Growing innovations: Due to a growth in the HIV incidences, there is a rise in the demand for HIV prevention and treatment approaches. This, in turn, is leading to their growing innovations, driving the clinical trials. Moreover, new collaborations are also being formed to accelerate these developments and clinical trials.

For instance,

• In July 2025, the initiation of the EXPrESSIVE phase 3 clinical trials of MK-8527, which is an oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) for HIV pre-exposure prophylaxis (PrEP), was announced by Merck. By collaborating with the Gates Foundation, the safety and efficacy of MK-8527 will be evaluated in women and adolescent girls in sub-Saharan Africa in the EXPrESSIVE-10 (MK-8527-010) trial, while the EXPrESSIVE-11 (MK-8527-011, NCT 07044297) trial will be conducted in people with HIV-1 exposure in 16 countries.
• In January 2025, the completion of participant enrollment was announced by HOOKIPA Pharma Inc. for its Phase 1b clinical trial for HB-500, which is a next-generation therapeutic vaccine for HIV, will be conducted in collaboration with Gilead Sciences. The HIV patients with ongoing antiretroviral treatment will be used as subjects to evaluate their safety, immune response, and tolerability.

HIV Clinical Trials Market Value Chain Analysis

R&D

The R&D for HIV clinical trials focuses on discovering, validating, and testing new vaccines, treatments, and prevention methods in human candidates to ensure their safety and effectiveness.

Key Players: Janssen Pharmaceuticals, Gilead Sciences, Merck & Co., ViiV Healthcare, Excision BioTherapeutics.

Clinical Trials and Regulatory Approvals

The clinical trials and regulatory approval of HIV clinical trials focus on conducting multi-phased studies for evaluating the safety and effectiveness profile of the treatments in human volunteers.

Key Players: Janssen Pharmaceuticals, Gilead Sciences, Merck & Co., ViiV Healthcare

Formulation and Final Dosage Preparation

The formulation in HIV clinical trials must be usable, stable, and effective, while the final dosage preparation involves the evaluation of safety, efficacy, concentration, and method of delivery.

Key Players: Gilead Sciences, ViiV Healthcare, Janssen Pharmaceuticals, Merck & Co.

Packaging and Serialization

The packaging and serialization of HIV clinical trials focus on ensuring the product integrity, unique identifiers for tracking, safe and secure delivery of investigational products, and preventing counterfeiting.

Key Players: Gilead Sciences, ViiV Healthcare, Janssen Pharmaceuticals

Patient Support and Services

The patient support and services of HIV clinical trials focus on helping the participants to overcome hurdles such as stigma and economic hardships by supplying them with medical, logistical, and psychological assistance and ensuring their consistent engagement in the trials, and enhancing their well-being.

Key Players: Gilead Sciences, ViiV Healthcare

Latest Announcements by Industry Leaders

In March 2025, after presenting the data of injectable HIV-1 capsid inhibitor that is once-yearly formulations of lenacapavir from its Phase 1 study, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences, Jared Baeten, stated that, to help people with the right HIV prevention choice, they are contributing to innovate additional person-centered long-acting injectables along with oral options. Moreover, the persistent challenges for people around the world wanting pre-exposure prophylaxis (PrEP) or to address PrEP adherence, the once-yearly lenacapavir can prove an important new HIV prevention option, if approved.

Recent Developments in the HIV Clinical Trials Market

• In July 2025, a clinical trial to evaluate Multiplo® TP/HIV rapid test as a self-test was announced to be initiated by MedMira Inc. and REACH Nexus. Moreover, with agreement from Health Canada, MedMira can avoid additional testing requirements and move forward with this label claim.
• In January 2025, the ACACIA (Antiretrovirals Combined with Antibodies for HIV-1 Cure in Africa) study, A5417, which is a phase 2, double-blind, randomized study, was opened by ACTG. The two long-acting broadly neutralizing antibodies (bNAbs) that is 10-1074-LS and 3BNC117-LS, for the HIV treatment will be evaluated for their virologic and immunologic effects, along with their safety in this trial.

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